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临床试验/NCT04277065
NCT04277065Unknown不适用

Short Outcomes Between Bulldog vs. Cotton Tourniquet in Laparoscopic Hepatectomy

hui hou1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
88
试验地点
1
主要终点
Blood loss

研究概览

简要总结

LLR was applied for tumors located at the lower edge and lateral segments of the liver that could be resected more easily than posterosuperior segments. With the development of technology and the growing experience of hepatobiliary surgeons, LLR has been expanded to major liver resections, anatomical resections, and donor hepatectomies by skilled surgeons. However, postoperative mortality, mobility and recovery of liver function are associated with major blood loss which is always the main cause of conversion to laparotomy and remains a challenge for surgeons. Pringle first described the method to arrest the hepatic hemorrhage by compression of the porta hepatis and this procedure was widely spread as well as in laparoscopic feild currently. Here, we described a new modified of Pringle maneuver using Bulldog to block vascular during LLR, and compared its effects with traditional pringle maneuver.

详细描述

With the innovations of laparoscopic technique and specialized equipment , laparoscopic liver resection became the dominating resection surgery approach. December of 2014, laparoscopic hepatectomy was carried out in our department, extracorporeal Pringle maneuver has been applied in most laparoscopic liver resections which need to block the hepatic inflow, cotton tape was the frequently used tourniquet. We used to blocked the hepatic inflow by extracorporeal Pringle maneuver method with cotton tape for its validity , softness and no visible damages for vessel, but it was always difficult for clamping in a two-dimensional view to encircle the hepatoduodenal ligament , and it delayed operation time for freshmen. Bulldog has been widely used in urinary surgery for vascular occlusion, but bulldog in hepatic surgery has rarely been mentioned, this is the first report to formally demonstrate the clinical application in hepatic surgery. However, it is not clear that whether the bulldog for vascular occlusion is useful and easy to implement in laparoscopic hepatectomy. In this study, we will compare the cotton and the bulldog for vascular occlusion during laparoscopic hepatectomy

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient who underwent hepatectomy for benign or malignant neoplasm of the liver, and is suitable for laparoscopic liver resection
  • Child-Pugh A without portal hypertension
  • No portosystemic shunt
  • No previous abdominal operation history
  • American society of anesthesiology class(ASA): I or II
  • Age 18 to 80

排除标准

  • Additional intervention to the liver (Radio Frequent Ablation, Percutaneous Ethanol. Injection Therapy or others)
  • Emergence hepatectomy
  • Previous hepatectomy
  • Combined operation for extrahepatic disease
  • Vulnerable population (mental retardation, pregnancy)

结局指标

主要结局

Blood loss

时间窗: intraoperative

the volume of blood loss

次要结局

  • Postoperative complication(Rates in different grades)(up to 30 days after liver resection)
  • Operation time(min)(intraoperative)
  • Duration to first flatus (days)(up to 14 days after liver resection)
  • Comfort questionnaire measures (GCQ) measures by Kolcaba(up to 30 days after liver resection)
  • Mortality rates(up to 30 days after liver resection)
  • Blood transfusion (times and units)(intraoperative)
  • Duration of abdominal drain (days)(up to 14 days after liver resection)
  • Hospital duration after operation (days)(up to 30 days after liver resection)
  • Intensive care unit stay(days)(up to 7 days after liver resection)
  • the clamping and declamping time(s)(intraoperative)
  • Liver functional recovery(up to 7 days after liver resection)

研究者

发起方
hui hou
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

hui hou

Director of the hepatobiliary surgery department

The Second Hospital of Anhui Medical University

研究点 (1)

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